Synthes 82-6828, Manual

Page: 7 / 104

7
Device
behavior
When the
Behavior
Occurs
Possible cause Recommended Solutions
Red status
LED is
illuminated
During sensor
reconnection
OR
At any time
during use
Damaged ICP Extension
Cable; damaged or faulty
DirectLink Module; or
damaged sensor.
a) Disconnect all cables from ICP
Module and the patient monitor.
b) Reconnect Patient Monitor
Interface Cable to the DirectLink
Module and to the patient
monitor. Verify that the self-test
completes successfully (solid
amber LED).
c) Connect the ICP Extension Cable
to the DirectLink Module without
the sensor attached and ensure
the solid amber LED remains lit. If
the red LED returns at this point,
perform a) and b). Then perform
c) with a new extension cable.
d) If the red LED returns, perform
a) and b). Then perform c) with a
new sensor.
e) If the red LED returns, replace the
DirectLink Module.
During sensor
zeroing
DirectLink memory may
be corrupted.
a) Disconnect all cables from the
ICP Module and the patient
monitor to reset/reboot the
device.
b) Reconnect to patient monitor/
extension cable and make sure
self-test completes successfully.
c) Ensure that sensor is prepared
for zeroing per the proper
technique outlined in the sensor’s
instructions for use. Repeat the
zeroing (by following Step 3 in
Section C. Zero the ICP Sensor ) or
resume monitoring [by following
Step 3 in Section F. Resume
Monitoring After Temporary
Disconnection (ACKNOWLEDGE
Function) ], as applicable.
d) If the red LED returns, replace the
DirectLink Module.
Amber
status LED
illuminates
(instead of
green LED
illuminating)
After a zeroing
attempt
1. The sensor has
already been
implanted.
2. The sensor vibrated/
was moved/was
touched during the
zeroing process.
3. The module is
damaged and cannot
perform zeroing.
4. The sensor is
damaged.
5. The Module is
experiencing electrical
interference from
other equipment.
Cause #1: Verify you are working
with an un-implanted probe. Probes
can only be zeroed before they are
implanted.
Causes #2, 3, & 4: To correct the
condition, repeat Step 3 in Section C.
Zero the ICP Sensor . If it fails again,
replace the DirectLink Module. If it
fails yet again, replace the sensor.
Cause #5: Make sure that all cables
connected to the DirectLink Module
are separated away from other
electrical equipment and cables.
Repeat Step 3 in Section C. Zero
ICP Sensor .
After a sensor
reconnection
attempt
DirectLink Module has
not detected a variable
signal from the sensor
that would correspond
to an implanted probe.
DirectLink system will
not allow this step for a
non-implanted probe.
Verify you are working with an
implanted probe and re-attempt
the reconnection process again,
by following the steps in Section F.
Resume Monitoring After Temporary
Disconnection (ACKNOWLEDGE
Function) .
Make sure that the sensor has not
become dislodged or has moved from
the original placement position in
the patient. Replace sensor if it has
become dislodged.
Maintenance
No yearly maintenance or calibration is required for the DirectLink
Module.
Service and Repair
The DirectLink Module and the DirectLink Extension Cable are
not repairable products; please contact your local Codman Neuro
Representative to order a replacement.
Product End of Life
The module contains electrical components. Dispose of the
equipment in accordance with local ordinances.
Warranty
Codman & Shurtleff, Inc. warrants that this medical device is free from
defects in both materials and workmanship for 1 year from the date of
purchase. THE ABOVE WARRANTIES ARE IN LIEU OF ALL OTHER
WARRANTIES EITHER EXPRESS OR IMPLIED, INCLUDING
ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. Suitability for use of this medical device
for any surgical procedure shall be determined by the user.
Neither Codman & Shurtleff nor its affiliated companies shall be
liable for incidental or consequential damages of any kind.
™ DirectLink is a trademark of DePuy Synthes Products, Inc.
® CODMAN MICROSENSOR is a registered trademark of
DePuy Synthes Products, Inc.
Appendix A
Electromagnetic compatibility
General Notes
Medical electrical equipment requires special precautions regarding
electromagnetic compatibility (EMC) and needs to be installed and
put into service according to the EMC information provided in this
document.
Portable and mobile RF communications equipment can affect
medical electrical equipment. The use of accessories and cables
other than those specified in this document, with the exception of
accessories and cables sold by the Manufacturer of the medical
electrical equipment as replacement parts for internal components,
may result in increased emissions or decreased immunity of the
Medical Electrical Equipment.
The equipment should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the equipment
should be observed to verify normal operation in the configuration in
which it will be used.
Table 1
Guidance and manufacturer’s declaration – electromagnetic emissions
The DirectLink is intended for use in the electromagnetic environment specified below. The
customer or the user of the DirectLink should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The DirectLink uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class A
The DirectLink is suitable for use in all establishments
other than domestic and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Not Applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not Applicable
Table 2
Guidance and manufacturer’s declaration – electromagnetic immunity
The DirectLink is intended for use in the electromagnetic environment specified below. The
customer or the user of the DirectLink should ensure that it is used in such an environment.
IMMUNITY test
IEC 60601
test level
Compliance level
Electromagnetic environment
– guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 2 kV for power
supply lines
± 1 kV for input/
output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
Not Applicable Not Applicable Not Applicable